Devices

Zimmer NexGen Augment

  • Model / Serial
    Part #00-5990-036-10;  lot 62815809
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
  • Product Description
    NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. || Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA